Brand Name Liability

So, the Supreme Court will decide two interesting cases. The one below will decide whether or not a brand name manufacturer can simply pay generic companies not to bring generic drugs to market:

WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90 percent

The second is whether or not generic manufacturers can be held liable if their drugs injure consumers. One of the arguments against letting generic manufacturers be sued is that they may take their products off the market due to the cost of litigation. This is an entirely false argument if for no other reason than generic manufacturers can buy insurance that covers any payouts.

But, if you accept the premise that it’s too important to make sure generic drugs are on the market to allow generic manufacturers to be sued, then you should also accept the premise that brand name companies shouldn’t be allowed to pay to keep generics off the market. It will be interesting to see which justices rule which way on both cases.

The U.S. Chamber of Commerce, the Business Council of Alabama, and four other groups also filed court briefs today supporting that request, saying the court’s earlier ruling could have far-sweeping consequences on healthcare, as well as other industries, in Alabama.

Here’s a hypothetical for you: A patient goes to see a doctor about chronic heartburn. The doctor thinks Reglan might be a good choice, so the doctor goes to the Physicians’ Desk Reference and reads the label for Reglan. That label was written by Wyeth, which was the brand-name manufacturer of Reglan. Based upon what was in the PDR, the doctor prescribes Reglan. The patient gets the prescription filled, but the pharmacist substitutes a generic version of Reglan. Eventually, the patient develops tardive dyskinesia and learns that the label for Reglan was filled with falsehoods. Had the label been truthful, the doctor would not have prescribed Reglan to the patient, and the patient would not have a movement disorder. Who should be liable, Wyeth or the generic manufacturer?

The pharmaceutical industry says neither company should be liable. Because the patient didn’t take a pill made by Wyeth, big pharma says Wyeth shouldn’t be liable even though it knowingly disseminated a false label. And the generic shouldn’t be liable in big pharma’s opinion because the generic supposedly can’t fix the false information in the label. (Yes, generics can, but that’s the subject of another post.)

Prior to 10/20/10, only one court in the country that I know of would hold Wyeth liable in that situation. That Court happened to be a California state court, and the decision was Conte v. Wyeth, 168 Cal.App.4th 89 (2008). To say that the pharmaceutical defense bar hates the Conte case is an understatement. Defense lawyers say “outlier” to describe Conte when they want to be kind, and “wacky California decision” when they express their true feelings.

I can only imagine that the order denying Wyeth’s motion for summary judgment in Kellogg v. Wyeth, 2:07-cv-00082 (D. Vt. Oct. 10, 2010) will give defense firms the sort of heartburn that Reglan was intended to treat. Here’s a very pertinent part of the order:

At issue is whether it is reasonably foreseeable that a doctor, in reliance upon false or misleading information disseminated by a brand name drug manufacturer, will write a prescription that will be filled by the bioequivalent generic form of the drug.

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Ultimately, although the decisions from other jurisdictions may offer insight, this Court seeks to follow the common law as it has developed in Vermont. There is no reason, under Vermont law, to limit Wyeth’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent drug to fill the physician’s prescription.

Finally, let me offer my hearty congratulations to Ralph Pittle, the Reglan lawyer behind Conte and Kellogg. Ralph is a good friend of mine, and I can honestly say he has the biggest heart of any lawyer I know.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.